Xenogenic collagen matrix or autologous connective tissue graft as adjunct to coronally advanced flaps for coverage of multiple adjacent gingival recession: Randomized trial assessing non‐inferiority in root coverage and superiority in oral health‐related quality of life |
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Authors: | Maurizio S Tonetti Pierpaolo Cortellini Gaia Pellegrini Michele Nieri Daniele Bonaccini Mario Allegri Philippe Bouchard Francesco Cairo Gianpaolo Conforti Ioannis Fourmousis Filippo Graziani Adrian Guerrero Jan Halben Jacques Malet Giulio Rasperini Heinz Topoll Hannes Wachtel Beat Wallkamm Ion Zabalegui Otto Zuhr |
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Institution: | 1. European Research Group on Periodontology, Genova, Italy;2. Department of Periodontology, Hong Kong University, Hong Kong, Hong Kong;3. Department of Biomedical, Surgical and Dental Sciences, University of Milano, Milano, Italy;4. Department of Surgery and Translational Medicine, University of Florence, Florence, Italy;5. Department of Periodontology, Service of Odontology, Rothschild Hospital, Denis Diderot University, Paris, France;6. Department of Periodontology, University of Florence, Florence, Italy;7. Department of Periodontology, University of Pisa, Pisa, Italy;8. University, U.F.R. of Odontology, Descartes University Paris, Paris, France;9. Department of Periodontology, University of Bern, Berne, Switzerland;10. Department of Periodontology, Johann Wolfgang Goethe University, Frankfurt/Main, Germany |
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Abstract: | Aim To evaluate the non‐inferiority of the adjunct of a xenogeneic collagen matrix (CMX) or connective tissue graft (CTG) to coronally advanced flaps (CAF) for coverage of multiple adjacent recessions and compare superiority in patient‐reported outcomes (PROM). Material and methods One hundred and eighty‐seven subjects (92 CMX) with 485 recessions in 14 centres were randomized and followed up for 6 months. Patients filled daily diaries for 15 days to monitor patient‐reported experience. The primary outcome was changed in position of the gingival margin. Multilevel analysis used centre, subject and tooth as levels and baseline parameters as covariates. Results Average baseline recession was 2.5 ± 1.0 mm. The surgery was 15.7 min shorter (95%CI from 11.9 to 19.6, p < .0001) and perceived lighter (11.9 VAS units, 95%CI from 4.6 to 19.1, p = .0014) in CMX subjects. Time to recovery was 1.8 days shorter in CMX. Six‐month root coverage was 1.7 ± 1.1 mm for CMX and 2.1 ± 1.0 mm for CTG (difference of 0.44 mm, 95%CI from 0.25 to 0.63 mm). The upper limit of the confidence interval was over the non‐inferiority margin of 0.25 mm. Odds of complete root coverage were significantly higher for CTG (OR = 4.0, 95% CI 1.8–8.8). Conclusion Replacing CTG with CMX shortens time to recovery and decreases morbidity, but the tested generation of devices is probably inferior to autologous CTG in terms of root coverage. Significant variability in PROMs was observed among centres. |
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Keywords: | collagen matrix coronally advanced flap gingival recession human randomized controlled clinical trial root coverage |
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